Abstract：
Conventional laparoscopic-assisted right hemicolectomy requires a small abdominal incision to extract the specimen, which becomes an important source of postoperative complications and impairs perioperative experience. Transvaginal natural orifice specimen extraction surgery (NOSES VIIIA) avoids this small incision by extracting the specimen through the vagina. Here we describe the design of a multicenter, open-label, parallel, noninferior, phase III randomized controlled trial (NCT05495048). The aim of this study is to confirm that the NOSES VIIIA procedure is not inferior to small-incision assisted right hemicolectomy in long-term oncological efficacy. A total of 352 female patients with right colon adenocarcinoma/high-grade intraepithelial neoplasia will be randomly assigned to the NOSES VIIIA arm and the small-incision arm in a 1:1 ratio. The primary end point of this trial is 3 year disease-free survival. Clinical Trial Registration: NCT05495048 (ClinicalTrials.gov).
摘要：
传统腹腔镜辅助右半结肠切除术需要腹部小切口来提取标本，成为术后并发症的重要来源,损害围手术期经验。经阴道自然孔口标本提取手术（NOSESVIIIA）通过阴道提取标本来避免这种小切口。在这里，我们描述了多中心的设计，开放标签，平行,非劣质,III期随机对照试验（NCT05495048）。这项研究的目的是确认在长期的肿瘤疗效上，NOSESVIIIA手术不逊于小切口辅助右半结肠切除术。共有352例右结肠腺癌/高级别上皮内瘤变的女性患者将以1：1的比例随机分配到NOSESVIIIA臂和小切口臂。该试验的主要终点是3年无病生存期。临床试验注册：NCT05495048（ClinicalTrials.gov）。
